Is ISO 9001 enough for a manufacturer of Ex equipment?
Abstract
No. ISO 9001 is a good base, but certified Ex production also needs the Ex-specific controls of ISO/IEC 80079-34, such as schedule drawing control, certificate-linked change control and routine tests, and approval by a notified body (QAN) or IECEx body (QAR).
No. An ISO 9001 certificate shows a working general quality management system, but it does not show that every unit is built exactly as certified. Manufacturers of certified Ex equipment are assessed against ISO/IEC 80079-34, which takes ISO 9001 clause by clause (its 2018 edition is built on ISO 9001:2015) and adds Ex-specific requirements, and their system must be approved by a notified body (a QAN under ATEX Module D or E) or audited by an IECEx certification body (a QAR). ISO 9001 is a strong starting point, not the finish line.
Short answer
- ISO 9001 is generic. It does not deal with certificates, schedule drawings, types of protection or Ex marking.
- ISO/IEC 80079-34:2018 (edition 2.0, the current edition; the draft of edition 3 has passed its enquiry vote and moved to the final draft stage) sets the minimum quality requirements for making Ex products in accordance with their certificates. It must be read with ISO 9001:2015.
- ISO 9001 itself has moved on: ISO 9001:2026 was published on 16 September 2026 and ISO lists the 2015 edition as withdrawn. Organisations certified to ISO 9001:2015 must move to the 2026 edition within the transition period set for accredited certification. Ask the certification body how it handles Ex audits until the revised ISO/IEC 80079-34 is published.
- ATEX: the Commission's ATEX Guidelines say a quality system based on EN ISO 9001 and EN ISO/IEC 80079-34 gives a presumption of conformity with Modules D and E, as far as those standards cover them and provided the system takes the specific products into account. Manufacturers may use other quality models, as long as they meet the module requirements.
- IECEx: every IECEx certificate of conformity requires a QAR on the manufacturing site; ISO/IEC 80079-34 states that it was prepared with the IECEx requirements in mind.
- An ISO 9001 certificate is not required by law, and holding one does not replace the notified body or IECEx audit.
What ISO/IEC 80079-34 adds to ISO 9001
The standard reproduces the relevant ISO 9001:2015 text and adds Ex requirements under the same clause numbers. The main additions, in plain terms:
| Area | ISO 9001 alone | Added for Ex products |
|---|---|---|
| Purpose of the system | Customer and regulatory requirements in general | Every Ex product made in accordance with its certificate and technical documentation |
| Documents | General document control | Distinction between schedule drawings (listed in the certificate) and related drawings, and control of the manufacturer's documentation against them |
| Changes | Control of changes in general | Changes that affect the certified design go through the certification body before production changes |
| Suppliers | Control of external providers | Control of purchased parts and processes that affect the type of protection, such as castings, cemented joints or safety components; an informative annex gives a model external provider's declaration of conformity |
| Release and testing | Release when planned arrangements are met | Routine verifications and tests required by the type of protection standards before release |
| Complaints | Customer complaints in general | Complaints defined to include safety and conformity of the product as described in the certificate |
An informative annex then gives guidance by type of protection. For flameproof enclosures it covers verification, castings, machining, cemented joints, routine overpressure testing and flanged joints. For intrinsic safety it covers safety-critical components, printed circuit boards, assemblies and routine tests. For increased safety it covers ingress protection, internal wiring and windings, and there is further guidance for other types.
Why ISO 9001 alone falls short
A type certificate covers one design defined by its schedule drawings. The real risk in production is a small, well-meant change: a different gasket supplier, a new casting source, a revised machining tolerance, a cheaper component in an intrinsically safe circuit. Under ISO 9001 such a change can be handled entirely inside the company. An Ex quality system has to check every such change against the certificate and its schedule drawings first; if the change touches them, the certification body must assess it before production changes. The ATEX directive itself requires manufacturers to tell the notified body about modifications to the approved type that may affect conformity (they need an addition to the EU-type examination certificate) and about intended changes to the quality system. Under IECEx, the certification body decides whether a design change needs a new issue of the certificate.
Example: A machine shop with ISO 9001 certification wins a contract to make flameproof enclosures under another firm's certificate. Its ISO 9001 system covers drawings and inspection, but the Ex audit also looks for: the schedule drawings and their revision status, checks of flamepath dimensions, routine overpressure test records where the standard requires them, control of the nameplates, and a rule that no drawing change reaches the shop floor without a certificate check. Each gap becomes a nonconformity before a QAN or QAR can be granted.
Common mistakes
- Showing the ISO 9001 certificate to a customer as proof of Ex production quality. Ask for the QAN or QAR instead.
- Treating ISO/IEC 80079-34 as a separate system. It is an extension of the ISO 9001 structure; one integrated system is normal.
- Excluding design or purchasing from the scope when they affect certified products.
- Forgetting subcontractors. The ATEX Guidelines state that a manufacturer cannot rely on notified body audits of third parties to discharge its own responsibility; the quality systems at the actual production sites, its own and its subcontractors', must be assessed by a notified body.
Related on excodex
- Quality assurance for Ex manufacturers: QAN, QAR and ISO/IEC 80079-34
- What is a QAN and why does an ATEX manufacturer need one?
- Does modifying certified Ex equipment void its certificate?
- Standard space: ISO/IEC 80079-34
Standards and further reading
- ISO/IEC 80079-34:2018, explosive atmospheres, part 34: application of quality management systems for Ex product manufacture (edition 2.0); webstore record: webstore.iec.ch; public preview with contents and scope: standards.iteh.ai
- ISO 9001:2015 and ISO 9001:2026 (edition 6, published 16 September 2026), quality management systems, requirements; transition dates: committee.iso.org
- Directive 2014/34/EU, Annex IV (Module D, quality system content and surveillance): legislation.gov.uk
- European Commission, ATEX 2014/34/EU Guidelines, 6th edition (January 2026), section on the quality system: webgate.ec.europa.eu
- IECEx, frequently asked questions on the Certified Equipment Scheme (QAR): iecex.com
This article is general technical information prepared by the excodex editorial team. It does not replace the applicable standards, the equipment certificates and instructions, national regulations or the assessment of a competent person.